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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735665
Device Problems Imprecision (1307); Audible Prompt/Feedback Problem (4020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9735736, serial/lot #: unknown. A medtronic representative went to the site to test the equipment. The navigation system passed the system checkout and was found to be fully functional. No parts were replaced on the system. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess). It was reported that there was an alleged inaccuracy during the case. It was also reported that the site was doing a trace registration and the minimum trace bar was filled but the software did not beep to indicate the minimum trace was complete. The medtronic representative had the surgeon remove the instrument from the field, bring it back and trace more and the system finally beeped to show minimum trace completed. The site was able to successfully pass a trace registration, but when verifying accuracy the probe was 5-7mm anterior of the patient¿s skin when touching the nose. The site re-registered and when verifying accuracy the probe was not 5mm superior to the nose. The site switched to another medtronic navigation system but the same inaccuracy occurred. The site chose to abort navigation. There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome. The medtronic representative who was present for the case mentioned that the patient exam was not optimal and the patient had a lot of deep grooved wrinkles on the face. It was later reported that the incorrect patient had been loaded, so the incorrect patient exam was in use.
 
Manufacturer Narrative
Device evaluation: an additional software analysis was completed for the minimum trace issue (not the alleged inaccuracy issue). However, the software analysis was unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction: other relevant device(s) are: product id: 9735736 (software version: 1. 2. 0). Device evaluation: a software analysis was completed. It was determined that the behavior described is the intended behavior of the software. The software was functioning as designed. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that at the last case the issue with minimum trace did not occur.
 
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Brand NameSTEALTHSTATION S8 PREMIUM SYSTEM
Type of DeviceEAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8791772
MDR Text Key151117245
Report Number1723170-2019-04098
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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